Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma

Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma

This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Carcinoma; Neoadjuvant Immunotherapy
• Intervention / Treatment: Drug: PD-1 blockade; Drug: Albumin paclitaxel; Drug: Carboplatin/Nedaplatin

• Study Type: Interventional
• Enrollment (Anticipated): 89
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qin Li, MD; Phone Number: 13701288153; Email: qinli128003@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Qin li
      • Contact: Qin Li, MD; Phone Number: 13701288153; Email: qinli128003@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age ≥ 18 years and ≤89 years;
2. pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
3. clinical stage II-IVA;
4. adequate organ function;
5. no previous chemotherapy or radiotherapy;
6. voluntarily signed informed consent.

Exclusion Criteria:

1. the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
2. patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
3. patients undergoing systemic corticosteroid or other immunosuppressive treatments;
4. patients with a history of allergy to the components of this test drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant PD-1 Blockade Plus Chemotherapy; PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles； Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles； Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.	Drug: PD-1 blockade; PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.; Drug: Albumin paclitaxel; Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.; Drug: Carboplatin/Nedaplatin; Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival (DFS)	Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic complete remission (PCR)	Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell.	4 weeks after surgery
Major Pathologic Response (MPR)	MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen.	4 weeks after surgery
Overall survival (OS)	Overall survival was defined as the time from randomization grouping to the time of death due to any cause.	24 months

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Nedaplatin
• Other Study ID Numbers: BeijingHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No